LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK

K122838 · Bio-Rad Laboratories · JJY · Oct 17, 2012 · Clinical Chemistry

Device Facts

• Record ID: K122838
• Device Name: LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK
• Applicant: Bio-Rad Laboratories
• Product Code: JJY · Clinical Chemistry
• Decision Date: Oct 17, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Liquichek Immunoassay Plus Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

Device Story

Liquichek Immunoassay Plus Control is a liquid, human serum-based quality control material containing added human/animal-derived constituents, chemicals, therapeutic drugs, stabilizers, and preservatives. Used in clinical laboratories to monitor the precision of immunoassay testing procedures. Laboratory personnel compare observed test results against manufacturer-provided mean values and ±3SD ranges to assess assay performance. The control helps identify variations caused by laboratory technique, instrumentation, or reagent changes, ensuring the reliability of patient test results. It is stored frozen (-20°C to -50°C) and has defined stability once thawed.

Clinical Evidence

Bench testing only. Stability studies were conducted to determine thawed opened and unopened stability. Acceptance criteria required recovery results to be within ±10% of the recovery result of a freshly opened vial.

Technological Characteristics

Human serum matrix; liquid form; contains various analytes, therapeutic drugs, and preservatives. Storage: -20°C to -50°C. Stability: 4 days thawed opened/unopened at 2-8°C; 28-month shelf life. No software or electronic components.

Indications for Use

Indicated for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for specific analytes in clinical laboratories. No specific patient population or contraindications are described.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

{0}

Statement for the Record, (k)122838

This 510(k) was reviewed under OIVD’s Pilot Triage Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.